Certificate
of Analysis
Enalapril Maleate USP24 Batch
No. : MIT505
Analysis No. :
01033 Mfg
Date :
May 15, 2001
Quantity :
25 Kg Expiry
Date : May, 2004
|
Item |
Specifications |
Result |
|
Appearance |
White crystalline powder |
White crystalline powder |
|
Identification |
IR Positive |
Conforms |
|
Melting
point |
142 to 147 oC |
144.0 to 145.0 oC |
|
Specific
rotation |
- 41.0 to - 43.5 o |
- 43.0 o |
|
Loss
on drying |
1.0 % max. |
0.02% |
|
Residue
on ignition |
0.2% max. |
0.04% |
|
Heavy
metal |
10 ppm max. |
< 10 ppm |
|
Organic
volatile impurities : Methylene
chloride Benzene Chloroform 1,4
dioxane Trichloroethylene |
< 600 ppm < 2 ppm < 60 ppm < 380 ppm < 80 ppm |
Conforms Conforms Conforms Conforms Conforms |
|
Impurities
: Enalaprilat Diketopiperazine Single
unknown impurity Total
unknown impurities |
0.2% max. 0.2% max. 0.2% max. 0.5% max. |
< 0.2%
max. < 0.2%
max. < 0.2%
max. < 0.5%
max. |
|
Assay |
98 to 102% |
100.11% |
|
Residual
solvent : Acetonitrile
Ethanol Methanol |
< 100 ppm < 100 ppm < 50 ppm |
18 ppm 39 ppm 28 ppm |
|
Conclusion : The
above mentioned product conforms to USP24 |
Date of analysis : May 16, 2001
Approved
